<?xml version="1.0" encoding="UTF-8"?>
<codeBook version="2.5" ID="FReSH-82586-en" xml-lang="en" xmlns="ddi:codebook:2_5" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:schemaLocation="ddi:codebook:2_5 https://ddialliance.org/Specification/DDI-Codebook/2.5/XMLSchema/codebook.xsd">
<docDscr>
  <citation>
    <titlStmt>
      <titl>MC Interventional Trial Protocol</titl>
      <IDNo>FReSH-82586-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="AGENCE NATIONALE DE LA RECHERCHE (ANR)" role="">Mariem Chaari</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                MC Interventional Trial Protocol            </titl>
      <altTitl>
                    Acronym for the study                </altTitl>
      <IDNo agency="FReSH-lang">
                FReSH-82586-en            </IDNo>
      <IDNo agency="Type d&amp;#039;identifiant de l&amp;#039;&#xE9;tude">
                    Identifiant de l&amp;#039;étude                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Mariem Chaari                                                <ExtLink title="ORCID" URI="null" role="pi id"/>
                                                                                                                    <ExtLink title="IdRef" URI="null" role="pi id"/>
                                                                                                                                                </AuthEnty>
      <AuthEnty affiliation="AGENCE REGIONALE DE SANTE HAUTS-DE-FRANCE (ARS)">
        <ExtLink title="SIREN" URI="130007974" role="organisation id"/>
      </AuthEnty>
      <AuthEnty>
        <ExtLink title="RNSR" URI="null" role="labo id"/>
      </AuthEnty>
      <othId affiliation="Pr&#xE9;nom du responsable de l&amp;#039 &#xE9;quipe PR&#xC9;NOM DU RESPONSABLE DE L&amp;#039 &#xC9;QUIPE" type="contributor">
        <ExtLink title="ORCID" URI="" role="team member id"/>
        <ExtLink title="IdRef" URI="" role="team member id"/>
      </othId>
      <othId affiliation="BAYER SAS" type="affiliation">
        <ExtLink title="SIREN" URI="562038893" role="organisation id"/>
        <ExtLink title="RNSR" URI="" role="labo id"/>
      </othId>
      <othId affiliation="" type="collaboration">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            BOEHRINGER INGELHEIM INTERNATIONAL GMBH                                            <ExtLink title="SIREN" URI="508241882" role="sponsor id"/>
                    
                </producer>
      <prodPlac>
                France Recherche en Santé Humaine (FReSH)            </prodPlac>
      <fundAg>
                                            CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT-ETIENNE                                            <ExtLink title="SIREN" URI="264200304"/>
                                            <ExtLink title="ROR" URI="https://ror.org/04pn6vp43"/>
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="AGENCE REGIONALE DE SANTE HAUTS-DE-FRANCE (ARS)" email="mariem.chaari@impactgroup.tech">
                    Mariem;Chaari
                                            <ExtLink title="SIREN" URI="130007974" role="organisation id"/>
                                            <ExtLink title="RNSR" URI="" role="labo id"/>
                                    </contact>
      <contact affiliation="BAYER SAS" email="qwerty@dd.tn">
                    Prénom du responsable de l&amp;#039;équipe ;PRÉNOM DU RESPONSABLE DE L&amp;#039;ÉQUIPE 
                                            <ExtLink title="SIREN" URI="562038893" role="organisation id"/>
                                            <ExtLink title="RNSR" URI="" role="labo id"/>
                                    </contact>
      <depDate date="2026-09-19"/>
      <distDate date="2026-09-19"/>
    </distStmt>
    <biblCit format="">
            </biblCit>
    <holdings URI="null"/>
    <notes> </notes>
  </citation>
  <studyAuthorization>
    <authorizingAgency>CNIL                </authorizingAgency>
  </studyAuthorization>
  <stdyInfo>
    <studyBudget/>
    <subject>
      <keyword vocab="" vocabURI="">
                    Hello</keyword>
      <topcClas vocab="health theme">
                        Addiction medicine                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/42d645e0-f58d-40ed-9917-5b227ff41a92"/>
                                                            <ExtLink title="MeSH" URI="D000073316"/>
                                                </topcClas>
      <topcClas vocab="health theme">
                        Emergency medicine                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/5e1591e2-d02b-436c-8216-6b8912eee467"/>
                                                            <ExtLink title="MeSH" URI="D004635"/>
                                                </topcClas>
      <topcClas vocab="health determinant">
                        Socio-demographic and economic determinants                    </topcClas>
      <topcClas vocab="health determinant">
                        Socio-demographic and economic determinants: Housing                    </topcClas>
    </subject>
    <abstract contentType="purpose">Objectives of the Study</abstract>
    <abstract contentType="abstract">Study Summary</abstract>
    <sumDscr>
      <collDate event="start" date="2026-08-03"/>
      <nation abbr="bz">
                    Belize
                                            <concept vocab="ISO" vocabURI="bz"/>
                                    </nation>
      <geogUnit/>
      <anlyUnit>
                Individus            </anlyUnit>
      <universe level="type" clusion="I">Patients population                    </universe>
      <universe level="sex" clusion="I">Male                                                            <concept vocab="MeSH" vocabURI="D008297"/>
                                                    </universe>
      <universe level="age" clusion="I">Child (6 to 12 years)                                                            <concept vocab="MeSH" vocabURI="D002648"/>
                                                    </universe>
      <universe clusion="I">Inclusion Criteria                    </universe>
      <universe clusion="E">Exclusion Criteria                    </universe>
      <dataKind>Clinical data</dataKind>
    </sumDscr>
    <qualityStatement>
      <standardsCompliance>
        <standard>
          <standardName>Standard(s) or bill of materials (BOM) used</standardName>
        </standard>
      </standardsCompliance>
    </qualityStatement>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Primary evaluation (or assessment) criterion</description>
    </developmentActivity>
    <developmentActivity type="secondary evaluation">
      <description>Secondary evaluation (or assessment) criterion(s)</description>
    </developmentActivity>
  </studyDevelopment>
  <method>
    <dataColl>
      <frequenc>Collection Frequency</frequenc>
      <sampProc>Complete enumeration (including consecutive recruitment)                                                            <concept vocab="CESSDA" vocabURI="TotalUniverseCompleteEnumeration"/>
                                                    </sampProc>
      <sampleFrame>
        <frameUnit>
          <unitType>Administrative database (employees</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>pupils</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>students</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>etc.)</unitType>
        </frameUnit>
      </sampleFrame>
      <targetSampleSize>
        <sampleSizeFormula>[500-1000[ individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <collMode>Interview with the participant (including clinical)                                                            <concept vocab="CESSDA" vocabURI="Interview"/>
                                                    </collMode>
      <sources>
        <sources>
          <sourceCitation>
                                    
                                    
                                                                    </sourceCitation>
        </sources>
      </sources>
    </dataColl>
    <notes>Interventional Study</notes>
    <notes subject="research type">
                        Interventional Study                    </notes>
    <anlyInfo>
      <respRate>750</respRate>
    </anlyInfo>
    <stdyClas>Ongoing study</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            To be defined                                                            <ExtLink title="COAR" URI="null"/>
                                                    </avlStatus>
    </setAvail>
    <useStmt>
      <contact email="vdfvdf@ddqsc.tn">ssss;SSS</contact>
    </useStmt>
  </dataAccs>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
